FDA.reportPublic FDA data

PMA P910056S040

Device
enVista One Piece Hydrophobic Acrylic Intraocular Lens (IOL)
Applicant
Bausch & Lomb, Inc.
PMA number
P910056
Supplement
S040
Product code
HQL
Decision date
2020-01-16
Generic name
intraocular lens
Approval order statement
Alternate milling process and an optional cleaning/drying step prior to batch milling for the enVista Hydrophobic Acrylic Intraocular Lenses, Models MX60, MX60E, MX60T, MX60ET and MX60PL.

Current openFDA PMA Record#

Device
enVista One Piece Hydrophobic Acrylic Intraocular Lens (IOL)
Applicant
Bausch & Lomb, Inc.
PMA number
P910056
Supplement
S040
Product code
HQL
Generic name
intraocular lens
Decision date
2020-01-16
Decision code
OK30
Date received
2019-12-20
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Alternate milling process and an optional cleaning/drying step prior to batch milling for the enVista Hydrophobic Acrylic Intraocular Lenses, Models MX60, MX60E, MX60T, MX60ET and MX60PL.